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  1. News & Events for Human Drugs

Virtual | Virtual

Event Title
Regulatory Education for Industry (REdI) Annual Conference 2023
June 5 - 9, 2023


Date:
June 5 - 9, 2023
Time:
8:40 AM - 4:30 PM ET

Topics & Presentations Day 1

Speakers

REdI Annual Conference 2023 – Day 1 – FDA Welcome and Keynote

 

FDA Welcome and Keynote Speaker

Robert M. Califf, MD
Commissioner of Food and Drugs
Food and Drug Administration

Plenary: User Fee Impact on FDA Programs.pdf

 

Jeff Shuren, MD, JD
Director
Center for Devices and Radiological Health (CDRH)

Patrizia Cavazzoni, MD
Director
Center for Drug Evaluation and Research (CDER)

Peter Marks, MD, PhD
Director
Center for Biologics Evaluation and Research (CBER)

REdI Annual Conference 2023 – Day 1 – Session 2

 

Biosimilar Program Updates and What’s New Under BsUFA III.pdf

Stacey Ricci, M.Eng, ScD,
Director of Scientific Review Staff (SRS)
Office of Therapeutic Biologics and Biosimilars (OTBB)
Office of New Drugs (OND) | CDER

Kimberly Maxfield, PhD
BsUFA Regulatory Science Program Coordinator
OTBB | OND | CDER

FDA Formal Meetings: What's New Under PDUFA, BsUFA, and OMUFA.pdf

Elizabeth Thompson, MS
Chief Project Management Staff
Division of Regulatory Operations for Nonprescription Drugs (DRO-NPD) Office of Regulatory Operations (ORO)
OND | CDER

Question and Answer Panel

Stacey Ricci, Kimberly Maxfield, and Elizabeth Thompson

REdI Annual Conference 2023 – Day 1 – Session 3

 

ESG (Electronic Submissions Gateway)…The Road to Modernization.pdf

Jessica Bernhardt, MS
AdminApps Program Manager, ESG Program Manager
Office of Information Management & Technology (OIMT)
Office of Digital Transformation (ODT)
Office of the Commissioner (OC)

eCTD v4.0 and Latest on eCTD.pdf

Jonathan Resnick
Project Management Officer
Division of Data Management Services and Solutions (DDMSS) Office of Business Informatics (OBI)
Office of Strategic Programs (OSP) | CDER

Electronic Submission Practicalities and Application Tips.pdf

Heather Crandall
Operations Research Analyst
DDMSS | OBI | OSP | CDER

Question and Answer Panel

Jessica Bernhardt, Jonathan Resnick, and Heather Crandall

REdI Annual Conference 2023 – Day 1 – Session 4

 

Data Standards.pdf

Hao (Ray) Wang
Director
Data Standards Staff (DSS)
Office of Strategic Program (OSP) | CDER

PDUFA VI Goals for Digital Health Technologies - A Regulatory Review Perspective.pdf

Andrew Potter
Mathematical Statistician
Division of Biometrics I (DBI)
Office of Biostatistics (OB)
Office of Translational Sciences (OTS) | CDER

PDUFA VII Goals for Digital Health Technologies (DHT) - An IT Perspective.pdf

Mary Ann Slack
Director
OSP | CDER

Question and Answer Panel

Hao (Ray) Wang, Andrew Potter, and Mary Ann Slack

 

Topics & Presentations Day 2

Speakers

REdI Annual Conference 2023 – Day 2 – Session 1

 

Leveraging SBIA's Resources.pdf

Renu Lal, PharmD, BCACP
Lieutenant Commander
United States Public Health Service (USPHS)
Team Lead, Division of Drug Information (DDI)
Deputy Director, SBIA
OCOMM | CDER

Overview of FDA Split Real Time Application Review (STAR) Pilot Program.pdf

LaShawn Schnupp, PharmD
Senior Regulatory Health Project Manager
STAR Program Manager
Program Development, Implementation, and Management Staff (PDIMS)
Office of Program Operations (OPO) | OND | CDER

J. Paul Phillips, MS
Director
OPO | OND | CDER

Use-Related Risk Analysis (URRA) and Human Factor (HF) Protocol Reviews: What to Submit for an Efficient Review.pdf

Lolita Sterrett, PharmD
Associate Director for Human Factors
Division of Medication Error Prevention and Analysis 2 (DMEPA 2) Office of Medication Error Prevention and Risk Management
(OMEPRM)
Office of Surveillance and Epidemiology (OSE) CDER

Question and Answer Panel

LaShawn Schnupp, J. Paul Phillips, and Lolita Sterrett

REdI Annual Conference 2023 – Day 2 – Session 2

 

The Modernization of Clinical Trials through Digital Health Technologies (DHT), Decentralized Clinical Trials (DCT) and Point of Care Trials.pdf

Beth Kunkoski
Health Science Policy Analyst
Clinical Methodologies
Office of Medical Policy (OMP) | CDER

PDUFA VII Real-World Evidence.pdf

Kimberly Smith
CAPT, USPHS
Real-World Evidence (RWE) Analytics OMP | CDER

Question and Answer Panel

Beth Kunkoski and Kimberly Smith

REdI Annual Conference 2023 – Day 2 – Session 3

 

PDUFA VII PMR (Postmarketing Requirements) Commitments: Preapproval & Postapproval.pdf

Kathleen (Kathy) Weil
Senior Science Policy Analyst
PMR/PMC Program Manager

Safety Policy Research and Initiatives Team (SPiRIT)
Immediate Office | OND | CDER

How CDER is Accelerating Rare Disease Cures and the PDUFA VII Rare Disease Endpoint Advancement Pilot Program.pdf

Kerry Jo Lee, MD
Associate Director for Rare Diseases
Rare Diseases Team
Division of Rare Diseases and Medical Genetics (DRDMG)
Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORDPURM)
OND | CDER

PDUFA VII Chemistry, Manufacturing, and Controls (CMC) Assessment Updates.pdf

Paresma Patel, PhD
Director
, Division of New Drug API (DNDAPI)
Office of New Drug Products (ONDP)
Office of Pharmaceutical Quality (OPQ) | CDER

Question and Answer Panel

Kathleen (Kathy) Weil, Kerry Jo Lee and Paresma Patel

REdI Annual Conference 2023 – Day 2 – Session 4 and Closing

 

Best Practices for Human Drug Product Recalls.pdf

Doris Chin
Consumer Safety Officer
Incidents, Recalls and Shortages Branch
Division of Supply Chain Integrity
Office of Drug Security, Integrity, and Response (OSDIR)
Office of Compliance (OC) | CDER

A Rough Guide to Biologics Manufacturing.pdf

Joel Welch, PhD
Associate Director for Science & Biosimilar Strategy
Chair for Emerging Technology Team
Office of Biotechnology Products (OBP)
OPQ | CDER

Chris Downey, PhD
Director, Division of Biotech Manufacturing
Office of Pharmaceutical Manufacturing Assessment (OPMA)
OPQ | CDER

Question and Answer Panel

Doris Chin, Joel Welch, and Chris Downey

Day Two Closing

Brenda Stodart, PharmD, BCGP, RAC-US
Captain, United States Public Health Service
Director, Small Business, and Industry Assistance (SBIA)
Division of Drug Information (DDI) | Office of Communications (OCOMM) | CDER

Visit CDER Small Business and Industry Assistance Page

June 7 Recording: Devices Track

June 8 Recording: Devices and Biologics Track

June 9 Recording: Biologics Track

Device Track Slides

Biologics Track Slides

Drugs, Devices, and Biologics

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.

 

Photo of Dr. Robert Califf

KEYNOTE SPEAKER
Robert M. Califf M.D., MACC
Commissioner of Food and Drugs

 

Patrizia Cavazzoni, M.D.

Patrizia Cavazzoni M.D.
Director
Center for Drug Evaluation and Research (CDER)

Photograph of Dr. Jeff Shuren

Jeff Shuren M.D., J.D.
Director
Center for Devices and Radiological Health (CDRH)

Dr. Peter Marks photograph

Peter Marks M.D., PhD.
Director
Center for Biologics Evaluation and Research (CBER)

 

NO COST Conference

Agenda

PLENARY

Federal law authorizes the FDA to collect user fees which help the FDA fulfill its mission of promoting and protecting the public health. Most major user fee programs run in five-year cycles, and the past year saw the launch of the current cycle for CDER, CBER, and CDRH. This session will take a closer look at the impact of user fee legislation, how the FDA advances programs through user fees support, and highlights of some of the exciting new efforts planned during this user fee cycle.

DRUGS TRACK

The drugs track will continue its focus on PDUFA VII commitments. Subject matter experts will provide cutting edge insights and perspectives on how several of these goals and initiatives are being implemented. Agenda topics will provide practical information and advances in bioinformatics (eCTD v4.0; ESG; data standards); digital health technologies, real-world evidence (RWE) & pilot programs.

Topics Include

  • New Meeting Types, including What's New Under PDUFA, BsUFA, and OMUFA
  • PDUFA VII Chemistry, Manufacturing, and Controls (CMC) Assessment Updates
  • Use-Related Risk Analysis (URRA) and Human Factor (HF) Protocol Reviews: What to Submit for an Efficient Review

Intended Audience

  • Regulatory affairs and other professionals working on the development and preparation of new drug submissions, drug safety and IT
  • Sponsors, applicant holders, manufacturers, clinical researchers and regulatory affairs professionals wishing to gain insight on INDs, NDAs and BLAs
  • Industry professionals at all levels of expertise

DEVICES TRACK

The devices track will provide an overview and highlights of how to get a new medical device to market. It will also discuss some best practices for ensuring that medical devices maintain their quality and continue to be safe and effective once on the market; and offer technical topic updates on biocompatibility, artificial intelligence, and radiological health.

Topics Include

  • Artificial Intelligence and Machine Learning; FDA Medical Device Inspections & Form FDA 483
  • Premarket Notification [510(k)] Program; Quality System Principles
  • Tips and Best Practices for High Quality Regulatory Submissions
  •  

Intended Audience

  • A new regulatory affairs specialist wanting to learn some basics and best practices for getting started with FDA’s regulation of medical devices.
  • A researcher of a medical device seeking to learn about the valid scientific evidence requirements needed to support new medical device regulatory submissions.
  • An establishment seeking to understand their regulatory responsibilities for handling complaints about their medical devices.

BIOLOGICS TRACK

The biologics track will focus on the developmental and regulatory topics relevant to advanced therapies, including cellular and gene therapies, tissue-engineered and other biological products. The speakers will present updates on programmatic enhancements mandated by PDUFA-VII, including new regulatory programs, stakeholder communications and much more.

Topics Include

  • IND readiness: contents of preclinical and clinical parts; Expanded Access INDs
  • Product development challenges and Chemistry, Manufacturing, and Controls (CMC) Developmental Readiness Pilot program
  • Estimand and Complex Innovative Design (CID) Program in application to CBER biologics

Intended Audience

  • Biotechnology product manufacturers, academic sponsors, and other stakeholders working on the development of advanced therapies
  • Regulatory affairs and other professionals working with submissions of INDs and BLAs to the Office of Therapeutic Products (OTP) in the Center for Biologics Evaluation and Research
  • Industry and consulting professionals working with advanced therapies, cell- or tissue-based products, and devices used with biological products

FDA RESOURCES

Plenary

Drugs

Devices

Biologics

 
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